Patients Can Be Monitored For Lymphoma Based On New Risk Factor

Biopsying the glands that produce saliva to test for germinal center-like formation when someone is diagnosed with primary Sj?¶gren’s Syndrome can predict later development of non-Hodgkin’s lymphoma, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

Sj?¶gren’s syndrome is an inflammatory disease that can affect many different parts of the body, but most often affects the tear and saliva glands. Patients with this condition may notice irritation, a gritty feeling, or painful burning in the eyes. Dry mouth or difficulty eating dry foods, and swelling of the glands around the face and neck are also common. Some patients experience dryness of other mucous membranes (such as the nasal passages, throat, and vagina) and skin. Between 400,000 and 3.1 million adults have Sj?¶gren’s syndrome. Primary Sj?¶gren’s syndrome occurs in people with no other rheumatic diseases. Secondary Sj?¶gren’s occurs in people who do have another rheumatologic disease, most often lupus and rheumatoid arthritis.

Germinal centers are sites within lymph nodes or lymph nodules where B cells maturate, proliferate, differentiate, and adapt as a component of the immune response. The centers develop dynamically after both B and T lymphocytes are activated after exposure to an antigen.

“Despite the fact that a connection between GC formation and lymphoma has been proposed and hypothesized, nobody has been able to prove this in an epidemiological setting in real patients,” explains Elke Theander, MD, PhD; head of the Department of Rheumatology at the Skane University Hospital, Malm?¶, Sweden and lead investigator in the study.

Until now, that is. Dr. Theander’s team recently followed patients from salivary gland biopsy until diagnosis of lymphoma, death, or end of follow up, which was anywhere from one month to 26 years. They reviewed 174 salivary gland biopsies from patients with primary Sj?¶gren’s syndrome for the presence of germinal center-like structures. The samples were examined using light-microscopy, and the pathologists who examined them did not know a patient’s status with regard to lymphoma nor did they have access to patient data such as their treatment or risk factors for Sj?¶gren’s.

Germinal center-like structures, defined for this study as a densely packed dark zone and a light zone in biopsies with classical focal infiltration within otherwise normal salivary glands, were detected in 43 biopsies. Seven of the patients studied developed non-Hodgkin’s lymphoma, six of whom had germinal center-like structures in their salivary gland biopsies at the time they were diagnosed with Sj?¶gren’s syndrome. The median time between salivary gland biopsy and non-Hodgkin’s lymphoma diagnosis was eight years.

Overall, patients with germinal center-like structures had a 15 times greater risk of developing non-Hodgkin’s lymphoma compared to those without. Furthermore, absence of these structures had a 99 percent negative predictive value suggesting that those patients would not go on to develop lymphoma.

“If germinal center-like structures are present in the diagnostic salivary gland biopsy, the patient should be followed and screened for possible lymphoma development, while patients without are less likely to develop the malignancy complication,” Dr. Theander says. “Being germinal-center positive might, under certain circumstances, support use of biological treatment, such as anti-B cell directed therapy. Still unclear is when to start such treatment.”

Source: American College of Rheumatology (ACR)

WHO Releases Report On Global Scale Of Drug-Resistant TB

Drug-resistant tuberculosis accounts for about one in every 20 new cases of TB diagnosed worldwide, and the number is closer to one in every five cases in some parts of the former Soviet Union, according to a World Health Organization report released Tuesday, the Washington Post reports (Brown, Washington Post, 2/27).

The report, titled “Anti-Tuberculosis Drug Resistance in the World,” estimates that there are about 500,000 new cases of multi-drug resistant TB annually, or about 5% of the nine million total new TB cases each year (Maugh, Los Angeles Times, 2/27). The report includes data collected between 2002 and 2006 from 90,000 people living with TB in 81 countries. It recorded the highest numbers of MDR-TB and found that extensively drug-resistant TB, which is resistant to the two most potent first-line treatments and some of the available second-line drugs, has been recorded in 45 countries worldwide. It is the first time that the survey included an analysis of XDR-TB, according to a WHO release (WHO release, 2/26).

In Baku, Azerbaijan, MDR-TB accounts for 22.3% of all new TB cases, which was the highest rate recorded (Altman, New York Times, 2/27). The percentage of MDR-TB among new TB cases was 19% in Moldova; 16% in Donetsk, Ukraine; 15% in the Tomsk region of Russia; and 15% in Tashkent, Uzbekistan (McKay, Wall Street Journal, 2/27). The percentages exceed the highest levels of MDR-TB published in WHO’s last TB report in 2004. The findings also show a link between HIV and MDR-TB. Among people with HIV/TB coinfection in Latvia and Ukraine, the report found that MDR-TB was almost twice as common compared with people who had TB and were HIV-negative (WHO release, 2/26). In addition, WHO said that in sub-Saharan Africa, HIV/AIDS is “dramatically fueling the spread of TB” (New York Times, 2/27). According to Mario Raviglione, director of WHO’s Stop TB Department, the “situation is going to go more quickly out of control because of the presence of HIV,” which leaves people more susceptible to TB.

High rates of drug-resistant TB also were found in China and India, the AP/Google reports. However, China disputed the data, saying that 94% of TB patients complete their first course of TB treatment in the country (Cheng, AP/Google, 2/26). In addition, the report highlighted TB control success in Estonia and Latvia, which were considered drug-resistant TB “hotspots” 13 years ago, Reuters Health reports. Significant investment and consistent efforts to control MDR-TB have helped stabilize rates of the disease in these countries, and notification rates also are declining, according to the report (Reuters Health, 2/26).

Although the report is the largest survey of drug-resistant TB, statistical information was only available from half of the world’s countries, and it includes information from six African countries (AP/Google, 2/26). According to the Los Angeles Times, many countries in sub-Saharan Africa were not able to report data because of a lack of laboratory capacity to diagnose drug-resistant TB (Los Angeles Times, 2/27). Raviglione said it is likely that a number of people with drug-resistant TB and even entire outbreaks are being missed. “We really don’t know what the situation is in Africa,” he said, adding that if MDR-TB has “penetrated Africa and coincides with AIDS, there’s bound to be a disaster” (AP/Google, 2/26).

According to the Post, WHO estimates that about $4.8 billion will be needed for overall TB control in low- and middle-income countries this year, or about $2.5 billion more than is available now (Washington Post, 2/27).

Reaction
“TB drug resistance needs a frontal assault,” Raviglione said, adding, “If countries and the international community fail to address it aggressively now, we will lose this battle.” He added, “In addition to specifically confronting drug-resistant TB and saving lives, programs worldwide must immediately improve their performance in diagnosing all TB cases rapidly and treat them until cured, which is the best way to prevent the development of drug resistance” (Reuters Health, 2/26).

Tido von Schoen-Angerer, executive director of Medecins Sans Frontieres Campaign for Access to Essential Medicines, said, “We are totally off-track right now,” adding that only 30,000 people with MDR-TB received treatment last year. MDR-TB is a “threat to every person on the planet,” according to Mark Harrington, executive director of the Treatment Action Group. “TB is a threat to every person who takes a train or a plane,” Harrington said (AP/Google, 2/26).


The report is available online.

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Anxiety And Mood Disorders Affect Many Affected By Katrina

A disproportionately high number of pre-Katrina New Orleans residents are affected by anxiety or mood disorders, according to an article published in Archives of General Psychiatry (JAMA/Archives). Approximately one quarter of residents who live in other affected areas also suffer from mood disorders and/or anxiety, the study reveals.

The authors explain “Hurricane Katrina was the worst natural disaster in the United States in the past 75 years, creating a disaster region as large as Great Britain, killing more than 1,000 people, uprooting 500,000 others and causing more than $100 billion in damage. This vast devastation would lead us to expect a high prevalence of mental illness among people who lived through Katrina.”

Sandro Galea, M.D., Dr. P.H., University of Michigan School of Public Health, Ann Arbor, and team carried out a telephone survey involving 1,043 residents who lived in the affected areas of Alabama, Mississippi, and Louisiana before Hurricane Katrina struck. The survey took place during Jan 19 – March 31, 2006, approximately 5-7 months after the disaster. The interviewees were asked about stressors related to the hurricane and checked for mood and anxiety disorder symptoms – these included panic disorders, depression, and PTSD (post-traumatic stress disorder), within 30 days of the interview.

The researchers found that;

– 31.2% of them had an anxiety-mood disorder (49.1% of New Orleans metropolitan area residents and 26.4% of other participants)

– 16.3% had PTSD (30.3% of New Orleans residents, 12.5% of others)

– A higher percentage of people suffered from an anxiety-mood disorder if they were under 60, female, non-graduates, unmarried, unemployed, and/or came from a low income home

– Hispanics had lower rates of anxiety mood disorders

The researchers wrote “The vast majority of respondents both in the New Orleans metro (91.9 percent) and in the remainder of the sample (81.7 percent) reported experiencing at least one of the 10 categories of hurricane-related stressors,” including the death of a family member, robbery, injury or property loss.

The researchers explained that the extent of exposure to these stressors was more closely linked to anxiety-mood disorders among New Orleans residents, compared to those from other areas. While New Orleans residents were the most susceptible to experiencing anxiety-mood disorders after physical illness, injury or physical adversity, the other residents were more prone to these disorders following property loss.

The authors found that the rate of these disorders among New Orleans residents was significantly higher than one would expect following a natural disaster in the USA. However, rates for those from other areas who were affected by Katrina were more-or-less equivalent.

“Evidence that avoidable stressors associated with the slow government response to Hurricane Katrina (e.g., physical adversity) had important implications for the mental health of people who lived through Katrina argues strongly for the importance of efficient provision of practical and logistical assistance in future disasters, not only on humanitarian grounds, but also as a way to minimize the adverse mental health effects of disasters,” the authors conclude.

“Exposure to Hurricane-Related Stressors and Mental Illness After Hurricane Katrina”
Sandro Galea, MD, DrPH; Chris R. Brewin, PhD; Michael Gruber, MA; Russell T. Jones, PhD; Daniel W. King, PhD; Lynda A. King, PhD; Richard J. McNally, PhD; Robert J. Ursano, MD; Maria Petukhova, PhD; Ronald C. Kessler, PhD
Arch Gen Psychiatry. 2007;64(12):1427-1434.
Click here to view abstract online

Substance In Red Grapes And Wine Key To Alzheimer’s Disease

Scientists at The Feinstein Institute for Medical Research
have figured out why a substance in red grapes and red wine lowers amyloid beta levels that accumulate in the brains of Alzheimer’s patients. Medicines targeting amyloid beta that make up the clumps in the hallmark plaques are now in many phases of experimental testing. The hope is that clearing out amyloid beta before it accumulates could stave off the disease and reduce symptoms. Scientists at the Feinstein hope to develop this natural substance, called resveratrol, or synthetic versions, for the treatment of Alzheimer’s.

Valorie Vingtdeux, PhD and their colleagues have discovered that a specific kinase – AMPK – controls Abeta levels. AMPK is an interesting protein because it is a metabolic sensor in the cells and throughout the body. It senses levels of ATP, the body’s fuel source. When ATP levels drop, AMPK is activated to prepare the cells to adjust to the metabolic change in the body – when fuel is low. It’s like a driver moving along at 50 and slowing down when it realizes that there is trouble ahead.

Resveratrol activates AMPK and in turn this protein lowers Abeta levels. Dr. Vingtdeux presented these findings at the Society for Neuroscience annual meeting in Washington, DC, this week. The work has been done so far in cell culture but Philippe Marambaud, PhD, who oversees the research, said there is every reason to believe that a similar process takes place in nature. “We hope that this result will translate into beneficial effects for Alzheimer’s patients someday,” said Dr. Marambaud. This is an important finding because the scientists identified a new potential molecular target – AMPK – to lower Abeta levels in Alzheimer’s. It also opens the door to considering more potent analogs of resveratrol. Feinstein scientists are now screening libraries of substances to see whether there are any compounds that could mimic the effects found in this substance. As it is, the amounts found in grapes and wine are small and it would not be feasible to ingest enough to have a benefit. The Feinstein chemists have identified several compounds that are now in different stages of testing.

Dt. Marambaud said that there are drugs available that are used for type 2 diabetes, metabolic syndrome and obesity that activate AMPK.

The Feinstein Institute for Medical Research

Increasing Incidence Of Rheumatoid Arthritis In Women

After four decades on the decline, rheumatoid arthritis is on the upswing among women in the United States. That’s the finding presented by Mayo Clinic investigators at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Francisco.

“This is a significant finding and an indicator that more research needs to be done to better understand the causes and treatment of this devastating disease,” says Sherine Gabriel, M.D., Mayo Clinic rheumatologist and lead investigator on the study.

From 1955 to 1994, the incidence of rheumatoid arthritis had continually been on the decline. That apparently changed beginning in the mid-1990s. When Mayo researchers analyzed patient data from early 1995 to the start of 2005, they found that both the incidence and prevalence (percentage) of the condition were rising.

Compared to the previous decade when approximately 36 women out of every 100,000 developed rheumatoid arthritis each year, the new study showed a jump to 54 women in the more recent decade. The incidence for men remained at about 29 per 100,000. Overall, the percentage of the entire population with the condition rose from 0.85 percent to 0.95 percent.

Researchers say it’s not clear why this is happening, but an environmental factor may have a role in the shifting incidence and prevalence among women.

The study included 350 adult patients from Olmsted County, MN, whose average age was 56.5 years. The majority, 69 percent, were women.

The research was supported by Mayo Clinic and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Others on the research team were Cynthia Crowson; Hilal Maradit-Kremers, M.D.; and Terry Therneau, Ph.D.

Source: Robert Nellis

Mayo Clinic

BUPA Launches Online Exercise Classes To Ease Arthritis Pain

Britain’s nine million arthritis sufferers can now find relief from symptoms and boost their wellbeing by following free online exercise videos launched today by Bupa, the health and care company.

The videos represent a first on the web for arthritis treatment .They’ve been developed with Bupa doctors and physiotherapists to educate people with arthritis about the benefits of gentle exercise in helping to relieve symptoms. This is in response to fears held by many arthritis sufferers that exercise may aggravate their condition.

Dr Annabel Bentley, assistant medical director at Bupa said: “Gentle exercise can be enormously beneficial for people with arthritis, helping to ease symptoms, strengthen joints and increase mobility. Our online exercise videos are designed to make it easier to do the right exercises with someone to follow and guide you through.”

There are five arthritis videos to choose from; one on general exercise and others looking at joint-specific exercises including knees, the back, shoulders and hands/wrists/forearms. Each video has a person demonstrating the exercises and a Bupa physiotherapist to guide you through.

The online arthritis exercise videos are the first in a series of free online videos from Bupa designed to provide users with practical hints, tips and advice on healthcare issues that matter today. Other videos will cover issues such as improving your health at work and give self-care advice, for example treating sprains and strains at home.

For more information or to view the videos visit hcd2.bupa/fact_sheets/html/arthritis.html or bupa/health
the videos are listed in the health factsheet section under rheumatoid arthritis.

The following videos can be viewed at
Should I exercise if I have arthritis?
What exercise can I do for arthritis in my hands, wrists and forearms?
What exercises can I do for arthritis in my shoulders?
What exercises can I do for arthritis in my back?
What exercises can I for do for arthritis in my knees?

Bupa is the UK market leader in health and care with a strong international presence. Established in 1947, it has around 10 million customers in almost 200 countries and more than 49,000 employees. Its main interests are health insurance, care homes for older people and young disabled, health assessments, workplace health and childcare services. Bupa Travel offers a bespoke travel insurance service. Sanitas in Spain, MBF, HBA, Mutual Community in Australia and DCA Agedcare in Australia and New Zealand, IHI in Denmark and Health Dialog in the US are all part of the Bupa Group which also has centres in Hong-Kong, Thailand and Saudi Arabia. Bupa is a company limited by guarantee and does not have a share capital. As a result, it can focus on its customers, helping them to live longer, healthier lives and can reinvest all of its profits to do this – this is the dividend that Bupa provides.

Source
Julie Urquhart
Bupa Corporate Communications

FDA Approves ZYFLO CR(TM) (Zileuton) Extended-Release Tablets For Critical Therapeutics, DEY Marketing Partner For Chronic Treatment Of Asthma

Dey, L.P. announced today that the
U.S. Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) of its marketing partner, Critical Therapeutics, Inc.
(Nasdaq: CRTX), for ZYFLO CR(TM) (zileuton) extended-release tablets. ZYFLO
CR(TM) offers twice-daily, extended-release dosing. Under a co-promotion
agreement executed between the two companies in March 2007, DEY will
co-market Critical Therapeutics’ ZYFLO CR(TM).

ZYFLO CR(TM) and ZYFLO(R) (zileuton tablets) are the only FDA-approved
leukotriene synthesis inhibitors for the prophylaxis and chronic treatment
of asthma in adults and children 12 years of age and older. ZYFLO CR(TM)
and ZYFLO(R) are not indicated for use in the reversal of bronchospasm in
acute asthma attacks, but can be continued during acute exacerbations of
asthma. Leukotrienes are inflammatory mediators in asthma that can trigger
asthma symptoms, including inflammation, swelling, bronchoconstriction and
mucus secretion. ZYFLO CR(TM) uses SkyePharma PLC’s (LSE: SKP) proprietary
Geomatrix(R) drug delivery technology, which controls the amount and rate
of drug released into the body.

“We applaud our marketing partner’s success in securing FDA approval of
the only twice-daily leukotriene synthesis inhibitor for asthma,” said Mel
Engle, President and CEO of DEY. “ZYFLO CR(TM) has a unique mechanism of ‘
action that, combined with its twice-daily dosing regimen, could
fundamentally expand and improve the treatment options available to asthma
patients. We are delighted to participate in commercializing Critical
Therapeutics’ ZYFLO CR(TM), which will continue to expand DEY’s presence in
asthma and respiratory care.”

In March 2007, Critical Therapeutics and DEY entered into an agreement
for the co-promotion of ZYFLO CR(TM) and ZYFLO(R), the immediate-release
formulation of zileuton. DEY’s sales force began promoting ZYFLO(R) on
April 30, 2007. Upon the launch of ZYFLO CR(TM), the combined sales forces
of the two companies will begin promoting ZYFLO CR(TM) to approximately
15,000 allergists, pulmonologists and primary care physicians across the
U.S.

About ZYFLO CR(TM) and ZYFLO(R)

ZYFLO CR(TM) and ZYFLO(R) are the only FDA-approved leukotrienes
synthesis inhibitors for the prophylaxis and chronic treatment of asthma in
adults and children 12 years of age and older. ZYFLO CR(TM) and ZYFLO(R)
are not indicated for use in the reversal of bronchospasm in acute asthma
attacks. Therapy with ZYFLO CR(TM) and ZYFLO(R) can be continued during
acute exacerbations of asthma.

The recommended dose of ZYFLO CR(TM) is two 600 mg extended-release
tablets twice daily, within one hour after morning and evening meals, for a
total daily dose of 2400 mg. The recommended dose of ZYFLO(R) is one 600 mg
immediate-release tablet four times a day for a total daily dose of 2400
mg.

ZYFLO CR(TM) and ZYFLO(R) are contraindicated in patients with active
liver disease or transaminase elevations greater than or equal to three
times the upper limit of normal. A small percentage of patients treated
with ZYFLO CR(TM) (2.5%) and ZYFLO(R) (1.9%) in placebo-controlled trials
showed an increased release of a liver enzyme known as ALT and bilirubin
(an orange or yellowish pigment in bile). As a result, the level of liver
enzymes in patients treated with ZYFLO CR(TM) and ZYFLO(R) should be
measured by a simple blood test. It is recommended that physicians perform
this test before administering ZYFLO CR(TM) and ZYFLO(R) and repeat the
test on a regular basis while patients are on the medication. Patients
taking ZYFLO CR(TM) and theophylline should reduce the theophylline dose by
50%. Patients taking ZYFLO CR(TM) and propranolol or warfarin should be
monitored and doses adjusted as appropriate. Most common side effects
associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis, nausea
and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea,
respectively.

About Dey, L.P.

Dey, L.P. is a specialty pharmaceutical company focused on the
development, manufacturing and marketing of prescription drug products for
the treatment of respiratory diseases, respiratory-related allergies, and
emergency care medicine. As the US leader in nebulized respiratory
medication, DEY puts patients first through its development of innovative
and affordable therapies. The Web sites for DEY include dey,
accuneb, curosurfusa, cyanokit, duoneb, epipen and perforomist. Dey, L.P. is an affiliate of Merck KGaA, Darmstadt, Germany.

ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CRTM is a trademark of Critical Therapeutics, Inc.

GEOMATRIX(R) is a registered trademark of SkyePharma PLC.

Dey, L.P.
dey

View drug information on Warfarin Sodium tablets; Zyflo.

EMEA Releases Guidelines On Development Of Medicines For Alzheimer’s Disease And Parkinson’s Disease

The European Medicines Agency (EMEA) has released two guidelines for
companies developing medicines for the treatment of Alzheimer’s disease
and other dementias, and for Parkinson’s disease, in the light of recent
scientific progress in the understanding of these diseases and
conditions.

Advances in clinical science, physiopathology and molecular biology have
stimulated new interest in the development of more effective symptomatic
or disease-modifying treatments, i.e. early treatments that may prevent
the emergence or slow down the progression of disease. The guidelines
were developed in response to the need of companies developing these new
types of medicines for guidance on appropriate clinical-trial designs.

As life expectancy increases, neurodegenerative diseases and dementia
will affect more and more people over the coming decades, and these
guidelines are expected to help improve the availability of medicines to
treat such diseases and conditions. The guidelines will come into effect
on 1 February 2009.

Scientific guidelines, which help companies to submit valid
marketing-authorisation applications for their medicines, are prepared
by the EMEA’s expert bodies, in this case the Committee for Medicinal
Products for Human Use (CHMP) and its relevant working parties, in
consultation with the Agency’s stakeholders. They reflect an approach to
specific scientific issues that is harmonised across the European Union
(EU), and are based on the most up-to-date scientific knowledge.
However, the recommendations they contain are not binding, and sponsors
may deviate from them, provided they can substantiate their approach.

The therapeutic area of neurodegenerative diseases is part of the
mandatory scope of the centralised procedure for the authorisation of
medicines. This means that, in the EU, all applications for marketing
authorisation for new medicines in this area have to be submitted to the
EMEA. The other therapeutic areas in the mandatory scope are: HIV/Aids,
cancer, diabetes, autoimmune diseases and other immune dysfunctions, and
viral diseases.

Notes

1. The ‘Guideline on medicinal products for the treatment of Alzheimer’s
disease and other dementias’ (CPMP/EWP/553/95 Rev.1) can be found
here (PDF). The ‘Guideline on
clinical investigation of medicinal products in the treatment of
Parkinson’s disease’ (CHMP/563/95 Rev.1) can be found
here (PDF).

2. These guidelines are substantially revised versions of earlier EMEA
guidelines, and have been updated to reflect new scientific
understanding of Alzheimer’s disease, dementia and Parkinson’s disease.

3. The guidelines were released for public consultation in July 2007.
Comments received during the consultation phase will be published on the
EMEA website shortly.

4. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website: emea.europa.eu

EMEA

Swine Flu And Asthma: NIH Prepares To launch 2009 H1N1 Influenza Vaccine Trial In People With Asthma

The National Institutes of Health is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease. The study is cosponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH.

“People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus,” says NIAID Director Anthony S. Fauci, M.D. “We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection.”

The study plan has been submitted to the Food and Drug Administration for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven sites across the United States that participate in NHLBI’s Severe Asthma Research Program.

This program already has a well-characterized group of participants with mild, moderate or severe asthma who may be eligible for this new study. These groups are largely distinguished by the amount and frequency of glucocorticoids needed to control asthma symptoms. People with mild disease may not need glucocorticoids, or may require low doses of inhaled glucocorticoids; those with moderate asthma need low to moderate doses of inhaled glucocorticoids; and those with severe asthma need high doses of inhaled glucocorticoids and frequently use oral glucocorticoids as well.

Individuals who already have been infected with 2009 H1N1 influenza or have received a 2009 H1N1 influenza vaccination will not be eligible for the study.

“The results of this study will have immediate implications for individuals with severe asthma as well as those who have milder asthma,” says NHLBI Director Elizabeth G. Nabel, M.D.

Early results from other clinical trials of 2009 H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of 2009 H1N1 influenza vaccine without adjuvant is well tolerated and induces a strong immune response in most participants. The same vaccine also generates an immune response that is expected to be protective in healthy children ages 10 to 17 years. Ongoing trials are comparing the immune response to one and two doses of 15- or 30-micrograms of vaccine given three weeks apart in various populations.

The Centers for Disease Control and Prevention has recommended that certain at-risk populations receive the new H1N1 vaccine as a priority before the general population. These target populations include pregnant women, health care providers and individuals with underlying chronic medical conditions, including asthma.

People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak a CDC review of hospital records found that people with asthma have a four-fold increased risk of being hospitalized with infection compared to the general population.

The study will enroll approximately 350 people with mild, moderate and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks that occur during the study period.

The vaccine to be used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.

The trial will be conducted at the following locations:
Cleveland Clinic, Ohio

Emory University, Atlanta

University of Pittsburgh Asthma Institute

University of Virginia, Charlottesville

University of Wisconsin, Madison

Wake Forest University, Winston-Salem, N.C.

Washington University School of Medicine, St. Louis

Detailed information about this study can be found on the ClinicalTrials Web site at clinicaltrials/ct2/results?term=H1N1+AND+asthma.

Source:
NIAID Office of Communications

NIH/National Institute of Allergy and Infectious Diseases

UnitedHealth Group Supports Tornado Victims In Southern States

UnitedHealth Group (NYSE: UNH) and its family of companies, including UnitedHealthcare, Ovations, AmeriChoice, OptumHealth and Prescription Solutions, are taking immediate action to assist people in the 17 county disaster area who may have been affected by the recent Mississippi tornadoes. This includes relief to health plan participants who may need to refill prescription medications that may have been misplaced as a result of the tornado; opening a free counseling help line; and a $20,000 donation toward the American Red Cross Disaster Relief Fund, which will help support people affected by the tornadoes in the Southeast United States.

- Early Prescription Refills: Individuals who have been displaced or do not have access to their medications, who call and identify that they have been affected by the tornado, will be able to have prescription medications filled if they have refills remaining on file at a participating retail or mail-order pharmacy.

This includes plan participants enrolled in all fully insured commercial products, Medicare Advantage, Medicare Supplement or Medicare Part D offerings, AARP MedicareRx plans and UnitedHealthcare Mississippi CHIP programs. For mail-order delivery service to affected areas or any other questions related to their prescriptions, people are encouraged to call the pharmacy number on the back of their ID card, or speak directly to a pharmacist about their situation.

This policy is effective immediately and will remain active until at least May 10, 2010.

- Help Line for Community Residents – OptumHealth, UnitedHealth Group’s health and wellness business, is providing a free help line for people coping with the emotional consequences of the tornadoes. Staffed by experienced master’s-level behavioral health specialists, the help line offers assistance to callers seeking help in dealing with stress, anxiety and the grieving process. Callers may also receive referrals to community resources to help them with specific concerns, such as financial and legal issues.

The toll-free help line number, 866-342-6892, is available 24 hours a day, seven days a week for as long as necessary. This service is free of charge to all Mississippians even if they are not UnitedHealthcare customers. Resources and information are also available online at liveandworkwell and in Spanish at mentesana-cuerposano.

- Support for the American Red Cross – A $20,000 donation will go to the American Red Cross Disaster Relief Fund from UnitedHealthcare, which provides services to the State of Mississippi under the Children’s Health Insurance Program, as well as to employer groups throughout the state.

“Our thoughts and prayers are with the people of Yazoo City and surrounding communities who suffered such tragic losses of life and property in this disaster,” said Norine Yukon, executive director of UnitedHealthcare Mississippi CHIP plan. “We recognize the Red Cross as an organization that can immediately have a positive impact for the people affected, and we want to support them as they assist Mississippians.”

UnitedHealth Group participates in the Annual Disaster Giving Program of the American Red Cross. The donation will allow the Red Cross to provide support for shelters, meals, and clean-up and comfort kits, as well as mental health support for families and the Yazoo City community.

“UnitedHealthcare is a committed partner of the Red Cross in disaster preparedness and relief,” said Michael Brown, vice president of Corporate and Foundation Partnerships at the American Red Cross. “Through their support of the Annual Disaster Giving Program, we are able to respond immediately to provide lifesaving services to families and communities during disasters like the recent tornado in Mississippi.”

People interested in providing additional assistance can contact the Red Cross Disaster Relief Fund to help provide food, shelter and counseling for people affected by disasters like the recent tornado by logging onto RedCross or by calling 1-800 RED CROSS (1-800-733-2767) or 1-800-257-7575 (Spanish) to make a donation. Contributions to the Disaster Relief Fund may also be sent to a local American Red Cross chapter or to the American Red Cross, P.O. Box 37243, Washington, D.C., 20013.

Source
American Red Cross
UnitedHealth Group